Medical Monitoring & Pharmacovigilance

ProSciento’s Medical Monitoring and Pharmacovigilance (PV) teams bring an unmatched level of scientific and therapeutic area expertise to ensure data integrity, safety, and mitigate risk 24/7 by working closely with clients, sites, and regulators.  Our physicians have a keen understanding of how to interpret pre-clinical, clinical, safety, and pharmacokinetics data to support effective dose escalation and safety reviews, and provide valuable expert input into phase 1 to 3 clinical study design, inclusion/exclusion criteria, PD/biomarker strategy, and regulatory requirements. For efficiencies and enhanced data transparency, we utilize a fully E2B (R3) compliant cloud-based PV system to enable fast evaluation of reportability, generation of regulatory reports, and signal detection.